Overview

This trial is active, not recruiting.

Condition obesity
Treatments electroacupuncture, sham electroacupuncture procedure
Phase phase 2
Sponsor Kyunghee University Medical Center
Start date January 2010
End date May 2010
Trial size 39 participants
Trial identifier NCT01102075, KOMC MIRB 2009-6

Summary

The purpose of this study is to determine whether electroacupuncture is effective on waist circumference in obesity.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
The Electroacupuncture therapy protocol included a total of 12 acupuncture points at the CV12,CV6, bilateral ST25, SP15, SP14,LI4, LI11, ST36, ST44. All acupuncture points were prepared with 70% alcohol pads, and disposable stainless steel needles were used. Abdominal acupuncture points were inserted horizontally 6~6.5cm in depth and the others were inserted vertically 2~2.5cm in depth until patient can feel De-Qi. All acupuncture points were stimulated electrically with a frequency of 24 Hz an intensity of 0.27-1.3mA(tolerable strength) with continuous stimulation by the pulse generator. The participants were given treatment twice a week for 30 minutes for 5 weeks by practitioner who had had 6 years of acupuncture training and 3 more years of clinical experience.
electroacupuncture EA group
We used Electrical stimulator(STN-111,Stratek)with a frequency of 24 Hz and intensity of 0.27-1.3mA(tolerable strength), asymmetric interactive pulse with continuous stimulation by the pulse generator. The participants were given treatment twice a week for 30 minutes for 5 weeks(10 sessions) by practitioner.(n=13)
(Sham Comparator)
The Sham electroacupuncture therapy protocol(Non-acupoint, No electrical stimulation)included the same number and type of needle, duration, frequency of sessions and practitioner as for the EA treatment, but superficially at non acupuncture points 15 mm to the lateral of each acupuncture point was treated. The points were not stimulated electrically, but the sound of the pulse generator was heard by the participants. (Lee SH, LeeBC 2009) Those receiving EA or SEA therapy were treated on alternate days to prevent crosstalk among groups, which could have compromised the blinded study design.
sham electroacupuncture procedure Sham EA group
We used same electroacupuncture device, number and type of needle, duration, frequency of sessions and practitioner as for the EA treatment. Specific details are as described in the arm description.(n=13)
(No Intervention)
No treatment was done for waiting group, but could receive same treatments as Electroacupuncture group after the end of trial.

Primary Outcomes

Measure
waist circumference
time frame: At 5 weeks (post treatment)

Secondary Outcomes

Measure
Thickness of abdominal subcutaneous fat
time frame: Study Day 1 (Baseline)
Thickness of abdominal subcutaneous fat
time frame: At 3weeks
Thickness of abdominal subcutaneous fat
time frame: At 5weeks (post treatment)
Thickness of abdominal subcutaneous fat
time frame: At 8weeks after first treatment (follow up)
Waist hip ratio
time frame: Study Day 1 (Baseline)
Waist hip ratio
time frame: At 3weeks
Waist hip ratio
time frame: At 5weeks (post treatment)
Waist hip ratio
time frame: At 8weeks after first treatment (follow up)
Body Mass Index
time frame: Study Day 1 (Baseline)
Body Mass Index
time frame: At 3weeks
Body Mass Index
time frame: At 5weeks (post treatment)
Body Mass Index
time frame: At 8weeks after first treatment (follow up)
Body fat ratio
time frame: Study Day 1 (Baseline)
Body fat ratio
time frame: At 3weeks
Body fat ratio
time frame: At 5weeks (post treatment)
Body fat ratio
time frame: At 8weeks after first treatment (follow up)
Visceral Fat Area
time frame: Study Day 1 (Baseline)
Visceral Fat Area
time frame: At 3weeks
Visceral Fat Area
time frame: At 5weeks (post treatment)
Visceral Fat Area
time frame: At 8weeks after first treatment (follow up)
Body weight
time frame: Study Day 1 (Baseline)
Body weight
time frame: At 3weeks
Body weight
time frame: At 5weeks (post treatment)
Body weight
time frame: At 8weeks after first treatment (follow up)
Obesity degree
time frame: Study Day 1 (Baseline)
Obesity degree
time frame: At 3weeks
Obesity degree
time frame: At 5weeks (post treatment)
Obesity degree
time frame: At 8weeks after first treatment (follow up)
Bulimia Test Revised
time frame: Study Day 1 (Baseline)
Bulimia Test Revised
time frame: At 5weeks (post treatment)
Korean version of Obesity-related QOL scale
time frame: Study Day 1 (Baseline)
Korean version of Obesity-related QOL scale
time frame: At 5weeks (post treatment)
Body Shape Questionnaire
time frame: Study Day 1 (Baseline)
Body Shape Questionnaire
time frame: At 5weeks (post treatment)

Eligibility Criteria

Male or female participants from 16 years up to 65 years old.

Inclusion Criteria: - Waist circumference: Male>= 90 cm, Female >= 85 cm - BMI over than 25kg/m2 Exclusion Criteria: - Secondary obesity caused by endocrine disease, e.g., polycystic ovary syndrome, diabetes mellitus, Cushing's syndrome, hypothyroidism etc. - Heart disease,e.g.,arrhythmia, heart failure, myocardial infarction, and patient with pacemaker - Hypertension, hyperlipidemia or hypercholesterinemia patients on medication - Stroke or otherwise unable to exercise - Pregnant or lactating women - Childbirth within 6 months - Management for weight control within 3 months - Any other conditions deemed unsuitable for trial as evaluated by the physician-in-charge

Additional Information

Official title The Effect of Low Frequency Electroacupuncture on Waist Circumference in Obesity-Three Arm Randomized Controlled Trial, Pilot Study
Principal investigator Sung Keel Kang, Doctor
Description Many studies have reported on the beneficial effects of acupuncture for obesity, although some negative reports also existed.(Wang F. et al. 2008)Recently conducted systematic review of Pittler and Ernst reported that there was insufficient, but not conclusive evidence to support the efficacy of acupuncture and acupressure for weight loss. However, most of these studies had methodological limitation, such as lack of adequate control group or unclear specific effect of electroacupuncture alone because auricular acupuncture was administered as well. In this sudy, we had three-arm randomized controlled trial(with sham control group) to investigate whether electroacupuncture is effective in the treatment of obesity.
Trial information was received from ClinicalTrials.gov and was last updated in April 2010.
Information provided to ClinicalTrials.gov by Kyunghee University Medical Center.